May 2011 By Apatech, Inc.
A multi-center, prospective, observational patient registry to collect information on the
clinical outcomes and "real world" use of approved and commercially available bone graft
substitutes, autograft and allograft.
||Observational Model: Cohort, Time Perspective: Prospective
|Ages Eligible for Study:||18 Years|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||No|
- The patient has failed conservative treatment and is a candidate for spinal fusion
- The patient is ?18 years old and of legal age of consent.
- The patient is, in the investigator's opinion, psychosocially, mentally, and
physically able to fully comply with this protocol, including the post-operative
regimen, required follow-up visits, the filling out of required forms, and have the
ability to understand and give written informed consent.
- The patient is skeletally mature (epiphyses closed).
- The patient has signed the IRB approved informed consent.
- The patient is willing and able to participate in post-operative clinical and
radiographic follow up evaluations for 2 years.
- Patient has systemic infection or infection at the surgical site.
- Patient has a medical condition that would interfere with post-operative assessments
and care (i.e., neuromuscular disease, psychiatric disease, paraplegia, quadriplegia,
- Patient is in poor general health or any concurrent disease process that would place
the patient in excessive risk to surgery (i.e., significant circulatory or pulmonary
problems, or cardiac disease).
- Patient has a history (present or past) of substance abuse (recreational drugs,
prescription drugs or alcohol) that in the investigator's opinion may interfere with
protocol assessments and/or with the patient's ability to complete the protocol
- The patient is pregnant/breastfeeding at the time of enrollment, or plans to become
pregnant during the course of the study.
- Patient is participating in another investigational study, which could confound